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Sample collection and shipment.

Though it is optional as to whether the detail of the procedure for biological or formulation sample collections is included in the actual protocol, as it can be detailed in the SOPs, we recommend that you do include it. Just listing the SOPs can make it difficult to track down details should there be questions at a later date. Include

  • sample volumes
  • range allowed outside of the targeted sampling time-points
  • types of vacutainers and collection vessels
  • special collection details
  • centrifugation speeds
  • short and long-term storage temperatures
  • sample labeling - not only should this be in compliance with GLP requirements, but you as the sponsor may have specific requirements as worked out with your analytical groups

Make sure to review all relevant biological and formulation handling SOPs during your site visit. Check that you are satisfied with the procedural documentation in the study notebook.

Work closely with your Pharmacokinetic and Clinical Pathology groups and Drug Development Team members to verify the appropriateness of collection, handling, and storage. Also discuss any special requirements from a physicochemical perspective with Pharmaceutical Technologies, such as whether the drug substance is adsorbed by glass or synthetic materials. This issue may be of especial concern with isolated tissue studies and loss of material onto the organ bath and tubing such as with Purkinje fiber preparations.

When shipping and managing samples for analysis consider the following

  • what shipping schedule should be followed (daily, weekly, end of study)
  • to whom will the samples be shipped and how will they be notified (this need not be documented in the protocol, although some sponsors may prefer to do so for added clarification rather than documentation only in the notebook)
  • how will the handover be managed in the event of shipping problems and what is an alternative contact procedure
  • are samples unstable, and do they require shipment on dry ice - if so avoid shipping over the weekend
  • schedule the analysis with your analytical group to coincide with draft and final report timelines
  • consider how and where in the study documentation findings will be presented and what are the acceptable concentration ranges in drug formulation samples
  • what is the turnaround time needed for pre-study screening samples to ensure data provision prior to commencing the actual dosing phase
  • determine what prioritization of analysis should be used where multiple parameters are to measured in the event of decreased sample size

Each part of your contracted study involves different challenges. In the case of collection and shipment of samples, several different groups are involved. Working out the timing, procedure, and practical logistics requires cooperation and a systematic approach to ensure that all relevant detail is gathered and considered. A central point of control performed by the study monitor to ensure that all involved parties are notified on an ongoing basis is critical.

Dr. Caroline Bell
Founder and CEO


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